Plymouth IndustrialREIT Declares Dividend for the Third Quarter of 2022

Plymouth IndustrialREIT Declares Dividend for the Third Quarter of 2022

BOSTON–(BUSINESS WIRE)–Plymouth Industrial REIT, Inc. (NYSE: PLYM) (the “Company”) today announced that its board of directors has declared a regular quarterly cash dividend of $0.22 per share of common stock for the third quarter of 2022. The dividend, which equates to an annualized rate of $0.88 per common share, is payable on October 31, 2022, to stockholders of record as of the close of business on September 30, 2022.

About Plymouth

Plymouth Industrial REIT, Inc. (NYSE: PLYM) is a real estate investment trust focused on the acquisition, ownership and management of single and multi-tenant industrial properties, including distribution centers, warehouses, light industrial and small bay industrial properties, located in primary and secondary markets within the main industrial, distribution and logistics corridors of the United States.

Tripp Sullivan

SCR Partners

(615) 942-7077

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Residential Building & Real Estate Commercial Building & Real Estate Construction & Property REIT

MEDIA:

Logo
Logo

Pebblebrook Hotel Trust Completes Sale of Hotel Vintage Portland

Pebblebrook Hotel Trust Completes Sale of Hotel Vintage Portland

BETHESDA, Md.–(BUSINESS WIRE)–
Pebblebrook Hotel Trust (NYSE: PEB) (the “Company”) today announced that on September 14, 2022, it closed on the sale of the 117-room Hotel Vintage Portland in Portland, OR for $32.9 million to a third party.

For the trailing twelve months ended June 30, 2022, the hotel’s net operating loss was ($0.1) million, and its Hotel EBITDA was $0.1 million. Based on the hotel’s operating performance for 2019, the $32.9 million sales price reflects an 11.7x EBITDA multiple and a 7.1% net operating income capitalization rate. The net operating income (loss) for both periods mentioned above is after an assumed annual capital reserve of 4.0% of total hotel revenues.

Proceeds from the sale of Hotel Vintage Portland will be used for general corporate purposes, which may include reducing the Company’s outstanding debt borrowings associated with recent hotel acquisitions, in accordance with the Company’s investment strategy.

About Pebblebrook Hotel Trust

Pebblebrook Hotel Trust (NYSE: PEB) is a publicly traded real estate investment trust (“REIT”) and the largest owner of urban and resort lifestyle hotels and resorts in the United States. The Company owns 51 hotels and resorts, totaling approximately 12,800 guest rooms across 15 urban and resort markets. For more information, visit www.pebblebrookhotels.com and follow us at @PebblebrookPEB.

This press release contains certain “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Reform Act of 1995. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “estimated” and “will” or other similar words or expressions. Forward-looking statements are based on certain assumptions and can include future expectations, future plans and strategies, financial and operating projections and forecasts and other forward-looking information and estimates. The intended use of proceeds is a forward-looking statement. These forward-looking statements are subject to various risks and uncertainties, many of which are beyond the Company’s control, which could cause actual results to differ materially from such statements. These risks and uncertainties include, but are not limited to, the state of the U.S. economy, the operating performance of our hotels and the supply of hotel properties, and other factors as are described in greater detail in the Company’s filings with the Securities and Exchange Commission, including, without limitation, the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. Unless legally required, the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

For further information about the Company’s business and financial results, please refer to the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” sections of the Company’s SEC filings, including, but not limited to, its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, copies of which may be obtained at the Investor Relations section of the Company’s website at www.pebblebrookhotels.com.

All information in this press release is as of September 15, 2022. The Company undertakes no duty to update the statements in this press release to conform the statements to actual results or changes in the Company’s expectations.

For additional information or to receive press releases via email, please visit our website at

www.pebblebrookhotels.com

Pebblebrook Hotel Trust
Hotel Vintage Portland
Reconciliation of Hotel Net Income to Hotel EBITDA and Hotel Net Operating Income
June 2022 Trailing Twelve Months
(Unaudited, in millions)
 

Twelve Months Ended

June 30,

2022

 
Hotel net income

($1.7)

 
Adjustment:
Depreciation and amortization

1.8

 
Hotel EBITDA

$0.1

 
Adjustment:
Capital reserve

(0.2)

 
Hotel Net Operating Income

($0.1)

 

This press release includes certain non-GAAP financial measures as defined under Securities and Exchange Commission (SEC) rules. These measures are not in accordance with, or an alternative to, measures prepared in accordance with U.S. generally accepted accounting principles, or GAAP, and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with the hotel’s results of operations determined in accordance with GAAP.

The Company has presented estimated trailing twelve-month hotel EBITDA and estimated trailing twelve-month hotel net operating income after capital reserves because it believes these measures provide investors and analysts with an understanding of the hotel-level operating performance. These non-GAAP measures do not represent amounts available for management’s discretionary use, because of needed capital replacement or expansion, debt service obligations or other commitments and uncertainties, nor are they indicative of funds available to fund the Company’s cash needs, including its ability to make distributions.

The Company’s presentation of the hotel’s estimated trailing twelve-month EBITDA and estimated trailing twelve-month net operating income after capital reserves should not be considered as an alternative to net income (computed in accordance with GAAP) as an indicator of the hotel’s financial performance. The table above is a reconciliation of the hotel’s estimated trailing twelve-month EBITDA and net operating income after capital reserves calculations to net income in accordance with GAAP. Any differences are a result of rounding.

Pebblebrook Hotel Trust
Hotel Vintage Portland
Reconciliation of Hotel Net Income to Hotel EBITDA and Hotel Net Operating Income
December 2019 Trailing Twelve Months
(Unaudited, in millions)
 
Twelve months ended
December 31,

2019

 
Hotel net income

$0.7

 
Adjustment:
Depreciation and amortization

2.1

 
Hotel EBITDA

$2.8

 
Adjustment:
Capital reserve

(0.5)

 
Hotel Net Operating Income

$2.3

 

This press release includes certain non-GAAP financial measures as defined under Securities and Exchange Commission (SEC) rules. These measures are not in accordance with, or an alternative to, measures prepared in accordance with U.S. generally accepted accounting principles, or GAAP, and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with the hotel’s results of operations determined in accordance with GAAP.

The Company has presented trailing twelve-month hotel EBITDA and trailing twelve-month hotel net operating income after capital reserves because it believes these measures provide investors and analysts with an understanding of the hotel-level operating performance. These non-GAAP measures do not represent amounts available for management’s discretionary use, because of needed capital replacement or expansion, debt service obligations or other commitments and uncertainties, nor are they indicative of funds available to fund the Company’s cash needs, including its ability to make distributions.

The Company’s presentation of the hotel’s trailing twelve-month EBITDA and trailing twelve-month net operating income after capital reserves should not be considered as an alternative to net income (computed in accordance with GAAP) as an indicator of the hotel’s financial performance. The table above is a reconciliation of the hotel’s trailing twelve-month EBITDA and net operating income after capital reserves calculations to net income in accordance with GAAP. Any differences are a result of rounding.

Pebblebrook Hotel Trust
Historical Operating Data
($ in millions, except ADR and RevPAR)
(Unaudited)
 
Historical Operating Data:

First Quarter

Second Quarter

Third Quarter

Fourth Quarter

Full Year

2019

2019

2019

2019

2019

 
Occupancy

75%

86%

86%

77%

81%

ADR

$253

$272

$269

$248

$261

RevPAR

$189

$234

$231

$191

$211

 
Hotel Revenues

$332.0

$409.5

$402.8

$350.0

$1,494.3

Hotel EBITDA

$89.2

$145.1

$136.6

$95.2

$466.2

Hotel EBITDA Margin

26.9%

35.4%

33.9%

27.2%

31.2%

 

First Quarter

 

Second Quarter

 

Third Quarter

 

Fourth Quarter

 

Full Year

 

 

2021

 

2021

 

2021

 

2021

 

2021

 
Occupancy

22%

43%

54%

52%

43%

ADR

$266

$265

$291

$265

$273

RevPAR

$60

$113

$157

$139

$117

 
Hotel Revenues

$109.7

$205.4

$280.1

$257.3

$852.4

Hotel EBITDA

($3.4)

$46.4

$84.1

$58.2

$185.4

Hotel EBITDA Margin

(3.1%)

22.6%

30.0%

22.6%

21.7%

 

First Quarter

 

Second Quarter

 

 

 

 

 

 

 

 

2022

 

2022

 
Occupancy

49%

69%

ADR

$311

$324

RevPAR

$151

$223

 
Hotel Revenues

$264.0

$396.9

Hotel EBITDA

$61.5

$138.7

Hotel EBITDA Margin

23.3%

34.9%

These historical hotel operating results include information for all of the hotels the Company owned as of September 14, 2022, following the sale of Hotel Vintage Portland. These historical operating results include periods prior to the Company’s ownership of the hotels. The information above does not reflect the Company’s corporate general and administrative expense, interest expense, property acquisition costs, depreciation and amortization, taxes and other expenses. Any differences are a result of rounding.

The information above has not been audited and has been presented only for comparison purposes.

Raymond D. Martz, Chief Financial Officer, Pebblebrook Hotel Trust – (240) 507-1330

KEYWORDS: Oregon Maryland United States North America

INDUSTRY KEYWORDS: REIT Lodging Commercial Building & Real Estate Construction & Property Travel

MEDIA:

Logo
Logo

Innovative Industrial Properties Declares Third Quarter 2022 Dividends

Innovative Industrial Properties Declares Third Quarter 2022 Dividends

Q3 2022 Cash Dividend of $1.80 per Common Share Contributes to Aggregate of $6.80 per Common Share for the Twelve Months Ending September 30, 2022, Up $1.34, or 25%, Over the Twelve Months Ended September 30, 2021

SAN DIEGO–(BUSINESS WIRE)–
Innovative Industrial Properties, Inc. (IIP), the first and only real estate company on the New York Stock Exchange (NYSE: IIPR) focused on the regulated U.S. cannabis industry, announced today that its board of directors has declared a third quarter 2022 dividend of $1.80 per share of common stock. The common stock dividends declared for the twelve months ending September 30, 2022, of $6.80 per common share represent an increase of $1.34, or 25%, over dividends declared for the twelve months ended September 30, 2021.

Additionally, IIP announced today that its board of directors has declared a regular quarterly dividend of $0.5625 per share of IIP’s 9.00% Series A Cumulative Redeemable Preferred Stock.

The dividends are payable on October 14, 2022 to stockholders of record at the close of business on September 30, 2022.

About Innovative Industrial Properties

Innovative Industrial Properties, Inc. is a self-advised Maryland corporation focused on the acquisition, ownership and management of specialized industrial properties leased to experienced, state-licensed operators for their regulated cannabis facilities. Innovative Industrial Properties, Inc. has elected to be taxed as a real estate investment trust, commencing with the year ended December 31, 2017. Additional information is available at www.innovativeindustrialproperties.com.

This press release contains statements that IIP believes to be “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than historical facts are forward-looking statements. When used in this press release, words such as IIP “expects,” “intends,” “plans,” “estimates,” “anticipates,” “believes” or “should” or the negative thereof or similar terminology are generally intended to identify forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in, or implied by, such statements. Investors should not place undue reliance upon forward-looking statements. IIP disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

IIP Contact:

Catherine Hastings

Chief Financial Officer

Innovative Industrial Properties, Inc.

(858) 997-3332

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Cannabis Search Engine Optimization Search Engine Marketing Specialty Natural Resources Commercial Building & Real Estate Construction & Property Retail Public Relations/Investor Relations Communications Alternative Medicine REIT Health

MEDIA:

Gap Inc. Canada Announces New Loyalty Rewards Program: One Membership. Four Brands

Canada NewsWire

Rewards members can now earn points and redeem rewards within one program while shopping in-store
and online at Old Navy, Gap, Banana Republic and Athleta

TORONTO , Sept. 15, 2022 /CNW/ – Today, Gap Inc. (NYSE: GPS) announced a new loyalty Rewards program across Canada: One Membership. Four Brands. The new program allows members to earn points, redeem rewards, and enjoy member benefits within our four brands: Old Navy, Gap, Banana Republic and Athleta.

With this new program, members can shop across all four brands and no matter which brand they enrolled in or how they spend, all their points will be in one place. It is easy for Rewards members to earn points, redeem rewards, and even give back by donating points to causes that drive social impact, which Gap Inc. will match, through our Do Good program. Rewards members will also receive special bonuses, and exclusive offers such as free shipping.

“Our program is designed to reward our loyal customers by creating unique, personalized experiences that will make it easier to shop, earn points and redeem rewards across our family of brands,” said Chris Samway, Head of Rewards, Loyalty & Payments at Gap Inc. “We’ve been piloting a version of this program in Canada for about a year and have seen great initial success. Our pilot has enabled us to incorporate valuable customer feedback, and now with an enhanced value proposition and a broader suite of benefits for our members, we’re excited to launch in Canada.”

The program will allow Rewards members to earn 1 point for every $1 spent. Members will be able to redeem rewards in $1 (or 100 point) increments.

The new program includes tiered membership levels based on annual spend:



Core



 ($0 – $


499


 Annual Spend)
 
  •  Free to join
  • Bonus points for shopping across the family of brands
  •  Birthday bonus
  •  Free shipping on orders of $50 or more


Enthusiast



($500$999 Annual Spend)
  • Core benefits listed above
  • Early access to new arrivals and sales
  • Members-only exclusive offers


Icon



 ($1,000+ Annual Spend)
  •  Core and Enthusiast benefits listed above
  •  Free shipping on orders of $35 or more
  •  Create Your Own Sale Day

Another key feature of the program is the Do Good component which gives customers the ability to donate their points to Canadian Women’s Foundation, a national leader in the movement for gender equality in Canada. In addition, Gap Inc. is matching up to $1 million of donations made by Rewards members across Canada and the U.S.

“We heard from our customers that they value brands that make a positive impact in the world,” said Samway. “With this in mind, we created a program where we can partner with our members to help make our communities stronger through supporting causes that drive social impact and deliver needed services to Canadians.”

The Gap Inc. Rewards program is now live for in-store and online enrollment for all Canadians. For more information, please visit: Navyist RewardsGap Good Rewards, Banana Republic Rewards, and Athleta Rewards.


About Gap Inc.
 

Gap Inc., a collection of purpose-led lifestyle brands, is the largest American specialty apparel company offering clothing, accessories, and personal care products for men, women, and children under the Old NavyGap, Banana Republic, and Athleta brands. The company uses omni-channel capabilities to bridge the digital world and physical stores to further enhance its shopping experience. Gap Inc. is guided by its purpose, Inclusive, by Design, and takes pride in creating products and experiences its customers love while doing right by its employees, communities, and planet. Gap Inc. products are available for purchase worldwide through company-operated stores, franchise stores, and e-commerce sites. Fiscal year 2021 net sales were $16.7 billion. For more information, please visit www.gapinc.com.


About the Canadian Women’s Foundation 

The Canadian Women’s Foundation is a national leader in the movement for gender equality in Canada. Through funding, research, advocacy, and knowledge sharing, we work to achieve systemic change. We support women, girls, and gender-diverse people to move out of violence, out of poverty, and into confidence and leadership. Since 1991, our generous donors and supporters have contributed more than $150 million to fund over 2,500 life-transforming programs throughout Canada.

SOURCE Gap Canada

Bristol Myers Squibb Announces Adjuvant Treatment with Opdivo (nivolumab) Demonstrated Statistically Significant and Clinically Meaningful Improvement in Recurrence-Free Survival (RFS) in Patients with Stage IIB/C Melanoma in the CheckMate -76K Trial

Bristol Myers Squibb Announces Adjuvant Treatment with Opdivo (nivolumab) Demonstrated Statistically Significant and Clinically Meaningful Improvement in Recurrence-Free Survival (RFS) in Patients with Stage IIB/C Melanoma in the CheckMate -76K Trial

Positive results from CheckMate -76K reinforce the potential benefit of Opdivo in earlier stages of melanoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the Phase 3 CheckMate -76K trial evaluating Opdivo (nivolumab) as a single agent in the adjuvant settingin patients with completely resected stage IIB/C melanoma met its primary endpoint and demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo at a pre-specified interim analysis. No new safety signals were observed at the time of the analysis.

CheckMate -76K is part of BMS’ development program studying Opdivo and Opdivo-based combinations in earlier stages of cancer, which currently spans seven tumor types.

“Stage IIB/C melanoma patients are at high risk of disease recurrence, with approximately one third of stage IIB and half of stage IIC patients experiencing recurrence within five years after surgery. The results of the CheckMate -76K study represent a significant advancement for patients with stage IIB/C melanoma and an extension of our legacy in the treatment of melanoma,” said Gina Fusaro, PhD, development program lead, melanoma, Bristol Myers Squibb. “Recurrence represents a life-altering event for people living with cancer. Treating with Opdivo in earlier stages of cancer, when the immune system may be more responsive, has the potential to help prevent recurrence – a critical goal of improving patient outcomes.”

The company will complete a full evaluation of the CheckMate -76K data and looks forward to sharing the results at an upcoming medical conference, as well as with health authorities. Bristol Myers Squibb thanks the patients and investigators who were involved in the CheckMate -76K clinical trial.

About CheckMate -76K

CheckMate -76K is a randomized Phase 3, double-blind study evaluating adjuvant Opdivo (nivolumab) 480 mg Q4W for up to 12 months versus placebo in patients with completely resected stage IIB/C melanoma.

The primary endpoint of the trial is recurrence-free survival (RFS). Secondary endpoints of the trial include overall survival (OS), distant metastases-free survival (DMFS), progression-free survival on next-line therapy (PFS2), and safety endpoints.

About Melanoma

Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. The incidence of melanoma has been increasing steadily for the last 30 years. In the United States, 99,780 new diagnoses of melanoma and about 7,650 related deaths are estimated for 2022. Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths. Melanomas can be mostly treatable when caught in very early stages; however, survival rates can decrease as the disease progresses.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

OPDIVO U.S. INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%).In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%).

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%).

In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, thyroiditis occurred in 2.7% (22/666) of patients, including Grade 3 (4.5%) and Grade 2 (2.2%).

In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hyperthyroidism occurred in 9% (42/456) of patients, including Grade 3 (0.9%) and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hyperthyroidism occurred in 12% (80/666) of patients, including Grade 3 (0.6%) and Grade 2 (4.5%).

In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypothyroidism occurred in 20% (91/456) of patients, including Grade 3 (0.4%) and Grade 2 (11%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypothyroidism occurred in 18% (122/666) of patients, including Grade 3 (0.6%) and Grade 2 (11%).

In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, diabetes occurred in 2.7% (15/666) of patients, including Grade 4 (0.6%), Grade 3 (0.3%), and Grade 2 (0.9%).

Immune-Mediated Nephritis with Renal Dysfunction

OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated nephritis with renal dysfunction occurred in 4.1% (27/666) of patients, including Grade 4 (0.6%), Grade 3 (1.1%), and Grade 2 (2.2%).

Immune-Mediated Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non- bullous/exfoliative rashes.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients, including Grade 3 (1.1%) and Grade 2 (2.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated rash occurred in 28% (127/456) of patients, including Grade 3 (4.8%) and Grade 2 (10%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated rash occurred in 16% (108/666) of patients, including Grade 3 (3.5%) and Grade 2 (4.2%).

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or OPDIVO in combination with YERVOY or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; other (hematologic/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: nervous system: autoimmune neuropathy (2%), myasthenic syndrome/myasthenia gravis, motor dysfunction; cardiovascular: angiopathy, temporal arteritis; ocular: blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: pancreatitis (1.3%); other (hematologic/immune): conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis.

Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.

Infusion-Related Reactions

OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30- minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 8% (4/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI- H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, infusion-related reactions occurred in 4.2% (5/119) of patients. In MPM patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, infusion-related reactions occurred in 12% (37/300) of patients.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with OPDIVO or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between OPDIVO or YERVOY and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO and YERVOY prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on its mechanism of action and findings from animal studies, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and YERVOY and for at least 5 months after the last dose.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

There are no data on the presence of OPDIVO or YERVOY in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 5 months after the last dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 238, serious adverse reactions occurred in 18% of patients receiving OPDIVO (n=452). Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. In Checkmate 816, serious adverse reactions occurred in 30% of patients (n=176) who were treated with OPDIVO in combination with platinum-doublet chemotherapy. Serious adverse reactions in >2% included pneumonia and vomiting. No fatal adverse reactions occurred in patients who received OPDIVO in combination with platinum-doublet chemotherapy. In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 057, fatal adverse reactions occurred; these included events of infection (7 patients, including one case of Pneumocystis jirovecii pneumonia), pulmonary embolism (4 patients), and limbic encephalitis (1 patient). In Checkmate 743, serious adverse reactions occurred in 54% of patients receiving OPDIVO plus

YERVOY. The most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism. Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY (n=547). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. In Checkmate 9ER, serious adverse reactions occurred in 48% of patients receiving OPDIVO and cabozantinib (n=320). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pneumonia, pneumonitis, pulmonary embolism, urinary tract infection, and hyponatremia. Fatal intestinal perforations occurred in 3 (0.9%) patients. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion- related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 274, serious adverse reactions occurred in 30% of patients receiving OPDIVO (n=351). The most frequent serious adverse reaction reported in ≥2% of patients receiving OPDIVO was urinary tract infection. Fatal adverse reactions occurred in 1% of patients; these included events of pneumonitis (0.6%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in ≥2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 59% of patients receiving OPDIVO with YERVOY (n=49). Serious adverse reactions reported in ≥4% of patients were pyrexia, diarrhea, anemia, increased AST, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin, and pneumonitis. In Attraction-3, serious adverse reactions occurred in 38% of patients receiving OPDIVO (n=209). Serious adverse reactions reported in ≥2% of patients who received OPDIVO were pneumonia, esophageal fistula, interstitial lung disease, and pyrexia. The following fatal adverse reactions occurred in patients who received OPDIVO: interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%). In Checkmate 577, serious adverse reactions occurred in 33% of patients receiving OPDIVO (n=532). A serious adverse reaction reported in ≥2% of patients who received OPDIVO was pneumonitis. A fatal reaction of myocardial infarction occurred in one patient who received OPDIVO. In Checkmate 648, serious adverse reactions occurred in 62% of patients receiving OPDIVO in combination with chemotherapy (n=310). The most frequent serious adverse reactions reported in ≥2% of patients who received OPDIVO with chemotherapy were pneumonia (11%), dysphagia (7%), esophageal stenosis (2.9%), acute kidney injury (2.9%), and pyrexia (2.3%). Fatal adverse reactions occurred in 5 (1.6%) patients who received OPDIVO in combination with chemotherapy; these included pneumonitis, pneumatosis intestinalis, pneumonia, and acute kidney injury. In Checkmate 648, serious adverse reactions occurred in 69% of patients receiving OPDIVO in combination with YERVOY (n=322). The most frequent serious adverse reactions reported in ≥2% who received OPDIVO in combination with YERVOY were pneumonia (10%), pyrexia (4.3%), pneumonitis (4.0%), aspiration pneumonia (3.7%), dysphagia (3.7%), hepatic function abnormal (2.8%), decreased appetite (2.8%), adrenal insufficiency (2.5%), and dehydration (2.5%). Fatal adverse reactions occurred in 5 (1.6%) patients who received OPDIVO in combination with YERVOY; these included pneumonitis, interstitial lung disease, pulmonary embolism, and acute respiratory distress syndrome. In Checkmate 649, serious adverse reactions occurred in 52% of patients treated with OPDIVO in combination with chemotherapy (n=782). The most frequent serious adverse reactions reported in ≥2% of patients treated with OPDIVO in combination with chemotherapy were vomiting (3.7%), pneumonia (3.6%), anemia (3.6%), pyrexia (2.8%), diarrhea (2.7%), febrile neutropenia (2.6%), and pneumonitis (2.4%). Fatal adverse reactions occurred in 16 (2.0%) patients who were treated with OPDIVO in combination with chemotherapy; these included pneumonitis (4 patients), febrile neutropenia (2 patients), stroke (2 patients), gastrointestinal toxicity, intestinal mucositis, septic shock, pneumonia, infection, gastrointestinal bleeding, mesenteric vessel thrombosis, and disseminated intravascular coagulation.

Common Adverse Reactions

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%). In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%). In Checkmate 816, the most common (>20%) adverse reactions in the OPDIVO plus chemotherapy arm (n=176) were nausea (38%), constipation (34%), fatigue (26%), decreased appetite (20%), and rash (20%). In Checkmate 227, the most common (≥20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%). In Checkmate 9LA, the most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%), and pruritus (21%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 743, the most common adverse reactions (≥20%) in patients receiving OPDIVO plus YERVOY were fatigue (43%), musculoskeletal pain (38%), rash (34%), diarrhea (32%), dyspnea (27%), nausea (24%), decreased appetite (24%), cough (23%), and pruritus (21%). In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) were fatigue (58%), rash (39%), diarrhea (38%), musculoskeletal pain (37%), pruritus (33%), nausea (30%), cough (28%), pyrexia (25%), arthralgia (23%), decreased appetite (21%), dyspnea (20%), and vomiting (20%). In Checkmate 9ER, the most common adverse reactions (≥20%) in patients receiving OPDIVO and cabozantinib (n=320) were diarrhea (64%), fatigue (51%), hepatotoxicity (44%), palmar-plantar erythrodysaesthesia syndrome (40%), stomatitis (37%), rash (36%), hypertension (36%), hypothyroidism (34%), musculoskeletal pain (33%), decreased appetite (28%), nausea (27%), dysgeusia (24%), abdominal pain (22%), cough (20%) and upper respiratory tract infection (20%). In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO (n=236) were cough (14%) and dyspnea (14%) at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In Checkmate 274, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=351) were rash (36%), fatigue (36%), diarrhea (30%), pruritus (30%), musculoskeletal pain (28%), and urinary tract infection (22%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO as a single agent (n=74), the most common adverse reactions (≥20%) were fatigue (54%), diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation (20%), and upper respiratory tract infection (20%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), the most common adverse reactions (≥20%) were fatigue (49%), diarrhea (45%), pyrexia (36%), musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%), rash (25%), decreased appetite (20%), and vomiting (20%). In Checkmate 040, the most common adverse reactions (≥20%) in patients receiving OPDIVO with YERVOY (n=49), were rash (53%), pruritus (53%), musculoskeletal pain (41%), diarrhea (39%), cough (37%), decreased appetite (35%), fatigue (27%), pyrexia (27%), abdominal pain (22%), headache (22%), nausea (20%), dizziness (20%), hypothyroidism (20%), and weight decreased (20%). In Attraction-3, the most common adverse reactions (≥20%) in OPDIVO-treated patients (n=209) were rash (22%) and decreased appetite (21%). In Checkmate 577, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=532) were fatigue (34%), diarrhea (29%), nausea (23%), rash (21%), musculoskeletal pain (21%), and cough (20%). In Checkmate 648, the most common adverse reactions (≥20%) in patients treated with OPDIVO in combination with chemotherapy (n=310) were nausea (65%), decreased appetite (51%), fatigue (47%), constipation (44%), stomatitis (44%), diarrhea (29%), and vomiting (23%). In Checkmate 648, the most common adverse reactions reported in ≥20% of patients treated with OPDIVO in combination with YERVOY were rash (31%), fatigue (28%), pyrexia (23%), nausea (22%), diarrhea (22%), and constipation (20%). In Checkmate 649, the most common adverse reactions (≥20%) in patients treated with OPDIVO in combination with chemotherapy (n=782) were peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), and musculoskeletal pain (20%).

Please see US Full Prescribing Information for OPDIVO and YERVOY.

Clinical Trials and Patient Populations

Checkmate 037–previously treated metastatic melanoma; Checkmate 066—previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 238–adjuvant treatment of melanoma; Checkmate 816–neoadjuvant non-small cell lung cancer, in combination with platinum-doublet chemotherapy; Checkmate 227—previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LA–previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 743–previously untreated unresectable malignant pleural mesothelioma, in combination with YERVOY; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 9ER–previously untreated renal cell carcinoma, in combination with cabozantinib; Checkmate 025–previously treated renal cell carcinoma; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 275–previously treated advanced or metastatic urothelial carcinoma; Checkmate 274–adjuvant treatment of urothelial carcinoma; Checkmate 142– MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040–hepatocellular carcinoma, in combination with YERVOY; Attraction-3–esophageal squamous cell carcinoma; Checkmate 577–adjuvant treatment of esophageal or gastroesophageal junction cancer; Checkmate 648—previously untreated, unresectable advanced, metastatic esophageal squamous cell carcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy; Checkmate 648— previously untreated, unresectable advanced, or metastatic esophageal squamous cell carcinoma, in combination with YERVOY ; Checkmate 649–previously untreated advanced or metastatic gastric or gastroesophageal junction or esophageal adenocarcinoma

About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that Opdivo (nivolumab) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such treatment for such additional indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2021, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

corporatefinancial-news

Bristol Myers Squibb

Media Inquiries:

[email protected]

Investors:

[email protected]

KEYWORDS: New Jersey United States North America

INDUSTRY KEYWORDS: Biotechnology FDA Health Other Health Radiology Pharmaceutical Oncology Other Science Research Managed Care Infectious Diseases Health Technology Science Clinical Trials

MEDIA:

Logo
Logo

Worthington Industries to Webcast Discussion of First Quarter 2023 Results on September 29

COLUMBUS, Ohio, Sept. 15, 2022 (GLOBE NEWSWIRE) — Worthington Industries, Inc. (NYSE:WOR) plans to release its first quarter results before the market opens on Thursday, Sept. 29, 2022. The Company will webcast a live discussion of these results that day at 8:30 a.m. ET. The webcast will be available at www.WorthingtonIndustries.com and will be archived for one year.

About Worthington Industries

Worthington Industries (NYSE:WOR) is a leading industrial manufacturing company pursuing its vision to be the transformative partner to its customers, a positive force for its communities and earn exceptional returns for its shareholders. For over six decades, the Company has been delivering innovative solutions to customers spanning industries such as automotive, energy, retail and construction. Worthington is North America’s premier value-added steel processor and producer of laser welded solutions and electrical steel laminations that provide lightweighting, safety critical and emission reducing components to the mobility market. Through on-board fueling systems and gas containment solutions, Worthington serves the growing global hydrogen ecosystem. The Company’s focus on innovation and manufacturing expertise extends to market-leading consumer products in tools, outdoor living and celebrations categories, sold under brand names, Coleman®, Bernzomatic®, Balloon Time®, Level5 Tools®, Mag Torch®, Well-X-Trol®, General®, Garden-Weasel®, Pactool International® and Hawkeye™; as well as market leading building products, including water systems, heating & cooling solutions, architectural and acoustical grid ceilings and metal framing and accessories.

Headquartered in Columbus, Ohio, Worthington operates 52 facilities in 15 states and nine countries, sells into over 90 countries and employs approximately 9,500 people. Founded in 1955, the Company follows a people-first philosophy with earning money for its shareholders as its first corporate goal. Relentlessly finding new ways to drive progress and transform, Worthington is committed to providing better solutions for customers and bettering the communities where it operates by reducing waste, supporting community-based non-profits and developing the next generations of makers.

Safe Harbor Statement

Worthington Industries wishes to take advantage of the Safe Harbor provisions included in the Private Securities Litigation Reform Act of 1995 (the “Act”). Statements by Worthington Industries which are not historical information constitute “forward looking statements” within the meaning of the Act. All forward-looking statements are subject to risks and uncertainties which could cause actual results to differ from those projected. Factors that could cause actual results to differ materially include risks, uncertainties and impacts described from time to time in Worthington Industries’ filings with the Securities and Exchange Commission, including those related to COVID-19 and the various actions taken in connection therewith, which could also heighten other risks.

Contacts:
SONYA L. HIGGINBOTHAM
VP, CORPORATE COMMUNICATIONS AND BRAND MANAGEMENT
614.438.7391 | [email protected]

MARCUS A. ROGIER

TREASURER AND INVESTOR RELATIONS OFFICER
614.840.4663 | [email protected]

200 Old Wilson Bridge Rd. | Columbus, Ohio 43085
WorthingtonIndustries.com



Quest Diagnostics Teams Up With Lee Health to Deliver High-Value, Innovative Laboratory Services

PR Newswire


SECAUCUS, N.J. and FORT MYERS, Fla.
, Sept. 15, 2022 /PRNewswire/ — Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, and Lee Health, Southwest Florida’s primary community-owned health system, are teaming up to enhance the quality and value of diagnostic services to patients and their doctors.

“We are excited to team up with Lee Health, a leading healthcare provider in Southwest Florida,” said Steve Rusckowski, Chairman, President and CEO, Quest Diagnostics. “As people return to care and hospitals contend with post-COVID challenges, hospital systems like Lee Health are turning to Quest for help on executing their lab strategy, taking advantage of our expertise, innovation and scale so they can focus on what they do best, providing quality care to their patients.” 

Under the agreement Quest will provide supply chain expertise in laboratory equipment, supplies and procurement processes for five hospitals owned by Lee Health and selected outpatient centers. Quest will also continue to perform reference testing for Lee Health. 

“We are pleased to partner with Quest Diagnostics to help us streamline our lab operations,” said Dr. Lawrence Antonucci, M.D., MBA, president and chief executive officer of Lee Health. “The ability to leverage Quest’s purchasing power for equipment and supplies and their expertise in supply chain logistics allows us to continue to provide high-quality care to our patients.”

About Quest Diagnostics 

Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world’s largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com 

About Lee Health

Since the opening of the first hospital in 1916, Lee Health has been a health care leader in Southwest Florida, constantly evolving to meet the needs of the community. A non-profit, integrated health care services organization, Lee Health is committed to the well-being of every individual served, focused on healthy living and maintaining good health. Staffed by caring people, inspiring health, services are conveniently located throughout the community in four acute care hospitals, two specialty hospitals, outpatient centers, walk-in medical centers, primary care and specialty physician practices and other services across the continuum of care. Learn more at www.LeeHealth.org.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/quest-diagnostics-teams-up-with-lee-health-to-deliver-high-value-innovative-laboratory-services-301624668.html

SOURCE Quest Diagnostics

Graphex Technologies Announces Plans to Establish a New Shaping & Purification Pilot Plant in Michigan to Accelerate Domestication Efforts

To establish a robust graphite supply chain in the US, Graphex will process flake graphite from various geographical resources, will evaluate alternative purification methods, will investigate anode optimization strategies, and has commenced a search for additional plant locations to meet growing demand for domestic graphite supply chains.

ROYAL OAK, Mich., Sept. 15, 2022 (GLOBE NEWSWIRE) — Graphex Technologies, LLC, a wholly owned subsidiary of Graphex Group Limited (collectively “Graphex”) (NYSE American: GRFX | HKSE: 6128) and a global leader in mid-stream processing of natural graphite for use in lithium-ion (Li-ion) powered batteries, announced today that it intends to construct a pilot-scale shaping and purification processing facility at the same location as its pitch coating plant that is currently in development in Warren, MI. The pilot plant will be developed with Graphex’s established joint venture with Emerald Energy Solutions, LLC (“EES”).

As the EV industry continues to move toward domestication of the entire EV supply chain, Graphex is accelerating the advancement of mid-stream production processes of graphite. In line with the intentions of the Inflation Reduction Act and other recent legislative actions, this newly announced shaping & purification pilot plant coupled with the pitch coating plant already in development at the same location, will establish in the U.S. automotive center a full domestic processing from raw material to finished product – battery anode material for EV batteries. Additional benefits of the pilot include processing, validating, and testing spherical purified graphite and coated spherical purified graphite produced from flake graphite concentrate of various global sources, which will accelerate the qualification process of anode material from sources that are domestic and/or originated in countries with favorable trade agreements. The pilot plant will provide a platform to investigate advanced shaping, sizing, and coating technologies as well as evaluation and testing of alternative purification methods.

In parallel with the advancements made at the Warren facilities, and through the close alliance with its partners at EES, the Company plans to continue its expansion efforts by locating production facilities near concentrated point of use regions and in direct collaboration with customers. EES and the Company continue to explore new sites for additional mid-stream processing facilities in strategic locations in and around Warren, and around the country to address the gap between demand and current domestic production capabilities. With current projections for graphite demand nearing 200,000 tons per year and current domestic production at 0, one or two mid-stream plants will not be enough.

“Graphite is an essential component in EV batteries today and will remain a prevalent component for many years as EV demand increases. Graphex is taking steps to not only increase domestic production and diversify the upstream resources of this critical mineral, but to also continuously improve our technology and capabilities to meet the needs of the industry,” said John DeMaio, CEO of Graphex Technologies. “The OEMs and EV battery manufacturers require high quality, high volume, spherical graphite for their gigafactories and Graphex’s technical capability and operational agility will enable us to meet their needs.” Mr. DeMaio added that the development of a pilot-scale shaping and purification processing facility is keeping with Graphex’s long-standing and proud commitment to ESG (Environmental / Social / corporate Governance).

To learn more about these initiatives and more from Graphex Technologies, please visit www.graphexgroup.com

About Graphex
Graphex Technologies is a wholly owned U.S. subsidiary of Graphex Group Limited, a Cayman Island company with principal and administrative offices in Hong Kong and U.S.subsidiary office in Royal Oak, MI. Graphex is focused on the development of technologies and products to enhance renewable energy, particularly the enrichment of spherical graphite and graphene, key components for EV batteries and lithium-ion batteries for other use cases. Proficient in the commercial deep processing of graphite, Graphex has extensive commercial experience producing battery grade purified spherical graphite to the power battery market, currently at a volume of 10,000 metric tons per annum (tpa) with intentions to expand production to 40,000 tpa over the next three years. With a strategy to expand its global operations to support energy transition and electrification efforts worldwide, Graphex is currently among the top suppliers of specialized spherical graphite to the EV and renewable energy industries and holds patents in areas including products, production methods, machinery design, and environmental protection.

Forward Looking Statements

All statements contained in this presentation other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans and our objectives for future operations, are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the safe harbor in Section 27A and 21E of the Securities Act of 1933 and the Securities Exchange act of 1934, respectively. You can identify some of these forward looking statements by words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “likely,” “potential,” “continue” or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events that we believe may affect our financial condition, results of operations, business strategy and financial needs. We have based these forward looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short term and long-term business operations and objectives, and financial needs. These forward looking statements involve various risks and uncertainties.

Information from third sources identified in this release are based on published reports for such information and we have assumed the accuracy of such reports without independent investigation or inquiry.

This communication is for informational purposes only and is neither an offer to sell nor a solicitation of an offer to purchase any securities of Graphex Group Limited, including but not limited to its American Depositary Shares.


Media Contact:


FischTank PR
[email protected]



Altus Power, Inc. Announces Redemption of Public and Private Placement Warrants

Altus Power, Inc. Announces Redemption of Public and Private Placement Warrants

STAMFORD, Conn.–(BUSINESS WIRE)–
Altus Power, Inc. (NYSE: AMPS) (“Altus Power” or the “Company”), the premier independent developer, owner and operator of commercial-scale solar facilities, today announced that it will redeem all of its remaining public and private placement warrants (the “Warrants”) to purchase shares of Altus Power’s Class A common stock (the “Class A Common Stock”) that are governed by the Warrant Agreement, dated as of December 10, 2020 (the “Warrant Agreement”), by and among Altus Power, Inc., a Delaware corporation, and Continental Stock Transfer & Trust Company (“CST&T”), a Delaware corporation, as warrant agent and transfer agent and that remain outstanding following 5:00 p.m. New York City time on October 17, 2022 (the “Redemption Date”) for a redemption price of $0.10 per Warrant (the “Redemption Price”). Between May 31, 2022 and August 17, 2022, Altus Power exchanged approximately 4,630,163 public warrants for an aggregate of 1,111,243 of shares of its Class A Common Stock. Altus Power has not exchanged any of the private placement warrants as of this announcement.

Under Section 6.2 of the Warrant Agreement, Altus Power is entitled to redeem all of the outstanding Warrants at a redemption price of $0.10 per Warrant if the last reported sales price of the Class A Common Stock is at least $10.00 per share on any twenty trading days within the thirty trading day period ending on the third trading day prior to the date on which a notice of redemption is given. This share price performance requirement was satisfied as of September 12, 2022. CST&T, in its capacity as warrant agent, will be delivering a notice of redemption (the “Redemption Notice”) today to each of the registered holders of such outstanding Warrants on behalf of Altus Power.

All Warrants may be exercised by the holders thereof until 5:00 p.m. New York City time on the Redemption Date. Payment upon exercise of the Warrants may be made either (i) in cash, at an exercise price of $11.00 per Warrant (the “Cash Exercise Price”) or (ii) on a “cashless basis” in which the exercising holder will receive 0.2763 shares of Class A Common Stock for each Warrant. If any holder of Warrants would, after taking into account all of such holder’s Warrants exercised at one time, be entitled to receive a fractional interest in a share of Class A Common Stock, the number of shares the holder will be entitled to receive will be rounded down to the nearest whole number of shares.

Any Warrants that remain unexercised following 5:00 p.m. New York City time on the Redemption Date will be void and no longer exercisable, and the holders of those Warrants will be entitled to receive only the Redemption Price. The last day of trading of the Warrants, including on the New York Stock Exchange, will be October 14, 2022.

The shares of Class A Common Stock issuable upon exercise of the Warrants have been registered by Altus Power under the Securities Act of 1933, as amended, and are covered by a registration statement filed on Form S-1 with, and declared effective by, the Securities and Exchange Commission (Registration No. 333-262072).

Questions concerning redemption and exercise of the Warrants can be directed to Continental Stock Transfer & Trust Company,

One State Street, 30th Floor, New York, NY 10004, Attention: Compliance Department, Email [email protected].

For a copy of the Redemption Notice, please visit our investor relations website at https://investors.altuspower.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any Altus Power securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offering, solicitation or sale would be unlawful.

About Altus Power, Inc.

Altus Power, based in Stamford, Connecticut, is the premier commercial-scale clean electrification company, serving commercial, industrial, public sector and community solar customers with an end-to-end solution. Altus Power originates, develops, owns and operates locally sited solar generation, energy storage, and EV charging infrastructure across 18 states from Vermont to Hawaii. Visit www.altuspower.com to learn more.

Altus Power:

For Media:

Cory Ziskind

ICR, Inc.

[email protected]

For Investors:

Chris Shelton, Head of IR

Caldwell Bailey, ICR, Inc.

[email protected]

KEYWORDS: Connecticut United States North America

INDUSTRY KEYWORDS: Other Energy Technology Utilities Other Technology Alternative Energy Energy

MEDIA:

Logo
Logo

Pfizer Announces Positive Top-Line Results from Phase 3 Trial of Pentavalent Meningococcal Vaccine Candidate (MenABCWY) in Adolescents

Pfizer Announces Positive Top-Line Results from Phase 3 Trial of Pentavalent Meningococcal Vaccine Candidate (MenABCWY) in Adolescents

  • Phase 3 trial demonstrates that the investigational pentavalent meningococcal vaccine (MenABCWY) was well-tolerated with an acceptable safety profile and immunogenicity non-inferior to Trumenba® + Menveo® for all serogroups
  • Based on these findings, Pfizer plans to submit an application for approval to the U.S. Food and Drug Administration in the fourth quarter of 2022
  • If approved, MenABCWY could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine

NEW YORK–(BUSINESS WIRE)–
Pfizer Inc. (NYSE:PFE) today announced positive top-line results from the pivotal Phase 3 trial (NCT04440163) assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age. The trial met all primary and secondary endpoints, with the investigational vaccine demonstrating non-inferiority to licensed vaccines for the five meningococcal serogroups that cause the majority of invasive meningococcal disease: serogroups A, B, C, W and Y.1 Currently, MenACWY and MenB vaccines are licensed separately, and no single vaccine is available to help protect against the five serogroups.

Participants in the trial were randomly assigned to receive either two doses of MenABCWY or licensed vaccines (two doses of Trumenba® + one dose of Menveo®). Non-inferiority was demonstrated for all five serogroups following two doses of MenABCWY compared to two doses of Trumenba®and one dose of Menveo®.

Additionally, a single dose of MenABCWY met the non-inferiority criteria for serogroups A, C, W and Y compared to one dose of Menveo®. Furthermore, in individuals who had not previously received a meningococcal vaccine, the proportion of subjects with ≥4-fold increases in immune responses was observed to be higher following either one or two doses of MenABCWY for serogroups A, C, W and Y compared to one dose of Menveo®. Finally, the proportion of subjects with ≥4-fold increases in immune responses was also observed to be higher against all four serogroup B strains following two doses of MenABCWY compared to two doses of Trumenba®. The pentavalent vaccine candidate was well-tolerated, with a safety profile consistent with licensed vaccines.

“We are very pleased with these positive Phase 3 data, which are the first for a MenABCWY vaccine candidate,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “A pentavalent vaccine has the potential to help simplify what is currently a complex meningococcal vaccination schedule in the U.S. and improve vaccine coverage. Our goal is to help ensure as many adolescents and young adults as possible are protected against this devastating disease.”

Based on these Phase 3 results, which meet pre-determined criteria for licensure, Pfizer intends to submit a Biologics License Application to the U.S. Food and Drug Administration in the fourth quarter of this year. Submissions to additional regulatory authorities outside the U.S. are also planned.

“The potential recommendation of a pentavalent vaccine in the U.S. as an alternative to the existing MenACWY vaccines across both the 11- to 12-year-old and 16-year-old vaccination platforms provides a significant opportunity for Pfizer to enter the U.S. MenACWY vaccine market and help protect more young people across the country. Today, we estimate there are approximately 52 million adolescents and young adults who are in the age range for meningococcal vaccination according to CDC guidance,” said Angela Hwang, President, Global Biopharma Business, Pfizer. “We look forward to the public health impact a pentavalent vaccine may provide, and to strengthening our position as a global leader in the prevention of meningococcal disease.”

Potential Public Health Impact of a MenABCWY Vaccine

Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours, and for survivors can result in life-altering, significant long-term disabilities.2 Together, five serogroups (A, B, C, W and Y) account for 96 percent of all invasive meningococcal disease cases worldwide, with serogroup B accounting for the majority of disease in adolescents and young adults in the U.S. and Europe.3

In the U.S., the current vaccination recommendations for adolescents and young adults include a MenACWY vaccine and a separate MenB vaccine (total four doses) to help achieve the broadest protection available against meningococcal disease. However, less than a third of U.S. adolescents receive even one dose of a MenB vaccine, and fewer complete the two-dose series, resulting in many adolescents being unprotected against meningococcal disease caused by serogroups A, B, C, W, and Y.4,5 If approved and recommended, Pfizer’s pentavalent vaccine candidate could help simplify the meningococcal vaccination schedule by potentially reducing the total number of doses needed for individuals to be fully vaccinated against the five serogroups.6 Routine use of a MenABCWY vaccine could help improve meningococcal vaccination rates and coverage, thereby reducing cases of invasive meningococcal disease and associated mortality, the rate of long-term sequelae in survivors, and costs associated with controlling outbreaks.7

About the Phase 3 Trial

The randomized, active-controlled and observer-blinded Phase 3 trial of Pfizer’s pentavalent meningococcal vaccine candidate (NCT04440163) was initiated in June 2020 and enrolled 2,431 healthy adolescents and young adults (10 through 25 years of age) from the U.S. and Europe. The study was designed to compare immune responses in individuals after MenABCWY administration to responses in control groups receiving licensed vaccines Trumenba® (meningococcal group B vaccine) and Menveo® (meningococcal group A, C, W-135, and Y conjugate vaccine), as well as to describe the safety profile of the MenABCWY vaccine. Immune responses were assessed by human serum bactericidal assay (hSBA). The study enrolled both individuals who had previously received a MenACWY vaccine and those who had not. All participants had not received any meningococcal group B vaccine prior to enrollment.

Additional information about the trial can be found at www.clinicaltrials.gov. Pfizer plans to present the detailed results from this trial at a future medical congress and submit the results for peer review in a scientific journal.

Pfizer’s pentavalent meningococcal vaccine candidate combines its two licensed meningococcal vaccines, Trumenba® and Nimenrix® (meningococcal group A, C, W-135, and Y conjugate vaccine). Approvals of Nimenrix® and Trumenba® vary by country.

INDICATIONS FOR TRUMENBA® IN THE U.S.

  • Trumenba® is a vaccine indicated for individuals 10 through 25 years of age for active immunization to prevent invasive disease caused by Neisseria meningitidis group B

IMPORTANT SAFETY INFORMATION

  • Trumenba® should not be given to anyone with a history of a severe allergic reaction to any component of Trumenba®
  • Some individuals with weakened immune systems may have a reduced immune response
  • Persons with certain complement deficiencies and persons receiving treatments such as Soliris® (eculizumab), are at increased risk for invasive disease caused by Neisseria meningitidis group B even with receipt of vaccination with Trumenba®
  • Vaccination with Trumenba® may not protect all vaccine recipients against N meningitidis group B infections
  • Fainting can occur in association with administration of injectable vaccines, including Trumenba®
  • The most common adverse reactions in adolescents and young adults were pain at injection site, fatigue, headache, and muscle pain
  • Data are not available on the safety and effectiveness of using Trumenba® and other meningococcal group B vaccines interchangeably to complete the vaccination series
  • Tell your health care provider if you are pregnant, or plan to become pregnant
  • Ask your health care provider about the risks and benefits of Trumenba®. Only a health care provider can decide if Trumenba® is right for you or your child

INDICATION FOR NIMENRIX® IN THE E.U.

  • Nimenrix® is a vaccine indicated for individuals six weeks of age and older for active immunization to prevent invasive disease caused by Neisseria meningitidis groups A, C, W-135 and Y

IMPORTANT SAFETY INFORMATION

  • Nimenrix® should not be given to anyone with a history of a severe allergic reaction after a previous dose of Nimenrix®
  • Some individuals with weakened immune systems may have a reduced immune response
  • Persons with certain complement deficiencies and persons receiving treatments such as Soliris® (eculizumab), are at increased risk for invasive disease caused by Neisseria meningitidis groups A, C, W, and Y, even with receipt of vaccination with Nimenrix®
  • As with any vaccine, vaccination with Nimenrix® may not protect all vaccine recipients against N. meningitidis groups A, C, W and Y
  • Fainting can occur shortly before or after injecting vaccines, including Nimenrix®
  • The most common adverse reactions were loss of appetite, irritability, drowsiness, headache, fatigue, fever, and pain, redness, and swelling at the injection site
  • Tell your healthcare provider if you are pregnant, or plan to become pregnant
  • Ask your healthcare provider about the risks and benefits of Nimenrix®. Only a healthcare provider can decide if Nimenrix® is right for you or your child

Menveo® and Nimenrix® are trademarks of GlaxoSmithKline Biologicals S.A.

Soliris® is a trademark of Alexion Pharmaceuticals, Inc.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice: The information contained in this release is as of September 15, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer’s MenABCWY vaccine candidate, including its potential benefits, its potential recommendation and planned regulatory submissions, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any biologic license applications may be filed in any jurisdictions for Pfizer’s MenABCWY vaccine candidate; whether and when any such applications may be approved by regulatory authorities, which will depend on a myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether such product candidate will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s MenABCWY vaccine candidate; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities for Pfizer’s MenABCWY vaccine candidate and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results,” as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

______________________________

1 National Library of Medicine. Global estimate of Neisseria meningitidis serogroups proportion in invasive meningococcal disease: A systematic review and meta-analysis. September 2019. Available at: https://doi.org/10.1016/j.micpath.2019.103571. Accessed June 2, 2022.

2 Borg J, Christie D, Coen PG, Pooy R, Viner RM. Outcomes of Meningococcal disease in adolescence: prospective, matched-cohort study. Pediatrics. 2009;123:e502-e509.

3 Purmohamad A, Abasi E, Azimi T, Hosseini S, Hossein S, Nasiri M, Fooladi A. Global estimate of Neisseria meningitidis serogroups proportion in invasive meningococcal disease: A systematic review and meta-analysis. Microbial Pathogensis. 2019

4 Pingali C, Yankey D, Elam-Evans LD, et al. National Vaccination Coverage Among Adolescents Aged 13–17 Years — National Immunization Survey-Teen, United States, 2021. MMWR Morb Mortal Wkly Rep 2022;71:1101–1108. DOI: http://dx.doi.org/10.15585/mmwr.mm7135a1.

5 La EM, Garbinsky D, Hunter S, Poston S, Novy P, Ghaswalla P. Meningococcal B vaccination coverage among older adolescents in the United States. Vaccine. 2021;39(19):2660-2667.

6 National Library of Medicine. Rationale for the Development of a Pentavalent Meningococcal Vaccine: A US-Focused Review. 2022. Available at: https://pubmed.ncbi.nlm.nih.gov/35357651/

7 National Library of Medicine. Potential Public Health Impact of a Neisseria Meningitidis A, B, C, W, and Y Pentavalent Vaccine in the Unites States. 2022. Available at: https://pubmed.ncbi.nlm.nih.gov/33615973/

Media Relations

+1 (212) 733-1226

[email protected]

Investor Relations

+1 (212) 733-4848

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Health Consumer Infectious Diseases Children Clinical Trials Pharmaceutical Biotechnology

MEDIA:

Logo
Logo